Irrigant distribution system for electrodes

ABSTRACT

An ablation electrode assembly is provided with improved irrigation cooling of the assembly and ablation site. The assembly includes a proximal end configured to be coupled to a catheter shaft and a distal end configured to deliver ablation energy to tissue. The assembly further includes a fluid manifold extending from the proximal end to the distal end and configured to fluidly communicate with a fluid lumen in the catheter shaft. The fluid manifold defines an axial passageway centered about a longitudinal axis extending in the longitudinal direction of the assembly. The axial passageway has a distal end terminating prior to the distal end of the electrode assembly. The assembly further includes means for creating turbulence in fluid exiting the first axial passageway.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.13/706,657, filed 6 Dec. 2012 (the '657 application), now U.S. Pat. No.9,066,725, issued 30 Jun. 2015. The '657 application is herebyincorporated by reference as though fully set forth herein.

BACKGROUND

a. Field

The instant disclosure relates generally to ablation electrodeassemblies and, in particular, to ablation electrode assemblies withimproved irrigation of the assembly and ablation site.

b. Background Art

Electrophysiology catheters are used in a variety of diagnostic and/ortherapeutic medical procedures to diagnose and/or correct conditionssuch as atrial arrhythmias, including for example, ectopic atrialtachycardia, atrial fibrillation, and atrial flutter. Arrhythmias cancreate a variety of conditions including irregular heart rhythms, lossof synchronous atrioventricular contractions and stasis of blood flow ina chamber of a heart which can lead to a variety of symptomatic andasymptomatic ailments and even death.

A medical procedure in which an electrophysiology catheter is usedincludes a first diagnostic catheter deployed through a patient'svasculature to a patient's heart or a chamber or vein thereof. Anelectrophysiology catheter that carries one or more electrodes can beused for cardiac mapping or diagnosis, ablation and/or other therapydelivery modes, or both. Once at the intended site, treatment caninclude application of, for example, radio frequency (RF) ablation,cryoablation, laser ablation, chemical ablation, high-intensity focusedultrasound-based ablation, microwave ablation. An electrophysiologycatheter imparts ablative energy to cardiac tissue to create one or morelesions in the cardiac tissue and oftentimes a contiguous or linear andtransmural lesion. This lesion disrupts undesirable cardiac activationpathways and thereby limits, corrals, or prevents errant conductionsignals that can form the basis for arrhythmias.

During RF ablation, local temperature elevation can result in coagulumformation on the ablation electrode, resulting in a local impedancerise. As the impedance increases, more energy is passed through theportion of the electrode without coagulum, creating even higher localtissue temperatures and further increasing coagulum formation and theimpedance. Finally, enough blood coagulates onto the electrode that noenergy passes into the targeted tissue, thereby requiring the catheterto be removed from the vascular system, the electrode to be cleaned, andthe catheter to be repositioned within the cardiac system at the desiredlocation. Not only can this process be time consuming, but it can bedifficult to return to the previous location because of the reducedelectrical activity in the tissue, which has been previously ablated.Recent studies have also demonstrated the formation of a so-called softthrombus in RF ablation. The formation of the soft thrombus results fromheat induced protein denaturation and aggregation and occursindependently of heparin concentration in serum. In addition, RFablation can generate significant heat, which, if not appropriatelycontrolled, can result in excessive tissue damage, such as tissuecharring, steam pop, and the like.

The foregoing discussion is intended only to illustrate the presentfield and should not be taken as a disavowal of claim scope.

BRIEF SUMMARY

In various embodiments, it may be desirable to have improved temperaturecorrelation between the ablation electrode assembly and the tissueinterface. It may also be desirable, in some embodiments, to include amechanism to irrigate the ablation electrode assemblies and/or targetedareas in a patient's body with biocompatible fluids, such as salinesolution, in order to inhibit charring and reduce the formation ofcoagulum, as well as to enable deeper and/or greater volume lesions ascompared to conventional, non-irrigated catheters at identical powersettings. This can, in turn, enable greater energy delivery during RFablation. The flow of biocompatible fluids (i.e., irrigation fluids) canbe turbulent in order to provide an enveloping flow pattern adjacent tothe surface of the ablation electrode assemblies for mixing with,displacing, and/or diluting blood in contact with the ablation electrodeassemblies to prevent stasis and the formation of coagulum. In addition,it may be desirable in some embodiments for the electrode to conform tocardiac anatomy in order to improve energy delivery during RF ablation.

An ablation electrode assembly in accordance with one embodiment of thepresent teachings includes a proximal end configured to be coupled to acatheter shaft and a distal end configured to deliver ablation energy totissue. The assembly further includes a fluid manifold extending fromthe proximal end to the distal end and configured to fluidly communicatewith a fluid lumen in the catheter shaft. The fluid manifold defines anaxial passageway defining a longitudinal axis extending in thelongitudinal direction of the assembly. The axial passageway has adistal end terminating prior to the distal end of the electrodeassembly. The fluid manifold further defines a plurality of angledpassageways extending from the distal end of the axial passagewaytowards the distal end of the electrode assembly. Each of the angledpassageways is in fluid communication with the axial passageway anddefines a proximal inlet port at the distal end of the axial passagewayand a distal outlet port with the distal outlet port nearer to thelongitudinal axis than the proximal inlet port.

An ablation electrode assembly in accordance with another embodiment ofthe present teachings includes a proximal end configured to be coupledto a catheter shaft and a distal end configured to deliver ablationenergy to tissue. The assembly further includes a fluid manifoldextending from the proximal end to the distal end and configured tofluidly communicate with a fluid lumen in the catheter shaft. The fluidmanifold defines an axial passageway centered about a longitudinal axisextending in the longitudinal direction of the assembly. The axialpassageway has a distal end terminating prior to the distal end of theelectrode assembly. The assembly further includes means for creatingturbulence in fluid exiting the axial passageway. This turbulent ordisturbed flow will cause the otherwise focused irrigant stream to slowand disperse closer to the ablation site thus promoting dilution andmovement of the blood pool surrounding the electrode

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic view of a system for performing one morediagnostic and/or therapeutic functions in association with cardiactissue.

FIG. 2 is an isometric partially transparent view of an ablationelectrode assembly in accordance with a first embodiment of thedisclosure.

FIG. 3 is a cross-sectional view of the ablation electrode assembly ofFIG. 2.

FIG. 4 is an isometric partially transparent view of the ablationelectrode assembly of FIG. 2 illustrating the flexibility of the outershell of the ablation electrode assembly of FIG. 2.

FIG. 5A is an isometric view of a portion of the outer shell of theablation electrode assembly of FIG. 2 in accordance with a firstembodiment.

FIG. 5B is an isometric view of a portion of the outer shell of theablation electrode assembly of FIG. 2 in accordance with a secondembodiment.

FIG. 6 is a plan view illustrating the flow of irrigant from theablation electrode assembly of FIGS. 2-4.

FIG. 7 is an isometric partially transparent view of an ablationelectrode assembly in accordance with a second embodiment of thedisclosure.

FIG. 8 is a cross-sectional view of the ablation electrode assembly ofFIG. 7.

FIG. 9 is an isometric partially transparent view of an ablationelectrode assembly in accordance with a third embodiment of thedisclosure.

FIG. 10 is an isometric partially transparent view of an ablationelectrode assembly in accordance with a fourth embodiment of thedisclosure.

FIG. 11 is an isometric partially transparent view of an ablationelectrode assembly in accordance with a fifth embodiment of thedisclosure.

FIG. 12 is a cross-sectional view of the ablation electrode assembly ofFIG. 11.

FIG. 13A is a plan view illustrating the flow of irrigant from anablation electrode assembly with a single distal port.

FIG. 13B is a plan view illustrating the flow of irrigant from theablation electrode assembly of FIGS. 11-12.

FIG. 14A is a cross-sectional view of an ablation electrode assembly inaccordance with a sixth embodiment of the disclosure.

FIG. 14B is a perspective view of a fluid deflector for use in anablation electrode assembly in accordance with a seventh embodiment ofthe disclosure.

FIGS. 15A-B are cross-sectional views of ablation electrode assembliesin accordance with seventh and eighth embodiments of the disclosure.

DETAILED DESCRIPTION

Various embodiments are directed to apparatuses, systems, and methodsfor the treatment of tissue. Numerous specific details are set forth toprovide a thorough understanding of the overall structure, function,manufacture, and use of the embodiments as described in thespecification and illustrated in the accompanying drawings. It will beunderstood by those skilled in the art, however, that the embodimentsmay be practiced without such specific details. In other instances,well-known operations, components, and elements have not been describedin detail so as not to obscure the embodiments described in thespecification. Those of ordinary skill in the art will understand thatthe embodiments described and illustrated herein are non-limitingexamples, and thus it can be appreciated that the specific structuraland functional details disclosed herein may be representative and do notnecessarily limit the scope of the embodiments, the scope of which isdefined solely by the appended claims.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment”, or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment,” or “in an embodiment”, or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation.

It will be appreciated that the terms “proximal” and “distal” may beused throughout the specification with reference to a clinicianmanipulating one end of an instrument used to treat a patient. The term“proximal” refers to the portion of the instrument closest to theclinician and the term “distal” refers to the portion located furthestfrom the clinician. It will be further appreciated that for concisenessand clarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the illustrated embodiments.However, surgical instruments may be used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

The instant disclosure generally relates to irrigated ablation electrodeassemblies. For purposes of this description, similar aspects among thevarious embodiments described herein will be referred to by similarreference numbers. As will be appreciated, however, the structure of thevarious aspects can be different among the various embodiments.

Referring to FIG. 1, an ablation electrode assembly 10 can comprise partof an irrigated catheter system 12 for examination, diagnosis, and/ortreatment of internal body tissues (e.g., targeted tissue areas 14). Inan exemplary embodiment, the irrigated catheter assembly can comprise anablation catheter 16 (e.g., radio frequency (RF), cryoablation,ultrasound, etc.). The instant disclosure generally refers to RFablation electrodes and electrode assemblies, but it is contemplatedthat the instant disclosure is equally applicable to any number of otherablation electrodes and electrode assemblies where the temperature ofthe device and of the targeted tissue areas can be factors duringdiagnostic and/or therapeutic medical procedures.

Still referring to FIG. 1, the irrigated catheter assembly includes acatheter shaft 18 that is an elongate, tubular, flexible memberconfigured for movement within a body. The catheter shaft 18 can beintroduced into a blood vessel or other structure within a body 20through a conventional introducer. The catheter shaft 18 can be steeredor guided through a body to a desired location such as targeted tissueareas 14 with pullwires, tension elements, so-called push elements, orother means known in the art.

The irrigated catheter assembly further includes at least one fluidlumen or fluid delivery tube 22 disposed within the catheter shaft 18,best shown in FIG. 2. The fluid delivery tube 22 is configured to supplyfluid to the ablation electrode assembly 10. Referring now to FIGS. 1-2,the fluid delivery tube 22 of the irrigated catheter assembly can beconnected to a fluid source 24 providing a biocompatible fluid such assaline, or a medicament, through a pump 26, which can comprise, forexample, a fixed rate roller pump or variable volume syringe pump with agravity feed supply from the fluid source for irrigation. The fluidsource 24 and/or pump 26 is conventional in the art. The fluid source 24and/or pump 26 can comprise a commercially available unit sold under thename Cool Point™, available from St. Jude Medical, Inc. in anembodiment.

Referring now to FIG. 1, the irrigated catheter assembly can furtherinclude one or more positioning electrodes 28 mounted in or on thecatheter shaft 18. The electrodes 28 can comprise, for example, ringelectrodes. The electrodes 28 can be used, for example, with avisualization, navigation, and mapping system 30. The electrodes 28 canbe configured to provide a signal indicative of both a position andorientation of at least a portion of the catheter shaft 18. Thevisualization, navigation, and/or mapping system 30 with which theelectrodes 28 can be used can comprise an electric field-based system,or, sometimes referred to as an impedance based system, such as, forexample, that having the model name ENSITE NAVX (aka EnSite Classic aswell as newer versions of the EnSite system, denoted as ENSITE VELOCITY)and commercially available from St. Jude Medical, Inc. and as generallyshown with reference to U.S. Pat. No. 7,263,397, the entire disclosureof which is incorporated herein by reference. The visualization,navigation, and/or mapping system 30 can include an electronic controlunit (ECU) and display device. The ECU can comprise a programmablemicroprocessor or microcontroller, but can alternatively comprise anapplication specific integrated circuit (ASIC). The ECU can include acentral processing unit (CPU) and an input/output (I/O) interfacethrough which the ECU can receive input data and can generate outputdata. The ECU can also have a memory, and the input data and/or outputdata acquired and generated by the ECU can be stored in the memory ofthe ECU.

In accordance with an electric field-based system, the electrodes 28 canbe configured to be responsive to an electric field transmitted withinthe body 20 of the patient. The electrodes 28 can be used to senseimpedance at a particular location and transmit a representative signalto an external computer or processor. In other exemplary embodiments,however, the visualization, navigation, and/or mapping system 30 cancomprise other types of systems, such as, for example and withoutlimitation: a magnetic field-based system such as the CARTO System (nowin a hybrid form with impedance- and magnetically-driven electrodes)available from Biosense Webster, and as generally shown with referenceto one or more of U.S. Pat. Nos. 6,498,944 and 6,690,963, the entiredisclosures of which are incorporated herein by reference, or theMediGuide™ system from St. Jude Medical, Inc., and as generally shownwith reference to one or more of U.S. Pat. Nos. 6,233,476, 7,197,354,and 7,386,339, the entire disclosures of which are incorporated hereinby reference. In accordance with a magnetic field-based system, thecatheter can be configured to include field sensors (e.g., coils)responsive to a magnetic field transmitted through the body 20 of thepatient to sense the strength of the field at a particular location andtransmit a representative signal to an external computer or processor.Such field sensors can comprise one or more metallic coils located on orwithin the catheter shaft 18 in a magnetic field-based system. As notedabove, a combination electric field-based and magnetic field-basedsystem such as the CARTO 3 System also available from Biosense Webster,and as generally shown with reference to U.S. Pat. No. 7,536,218, theentire disclosure of which is incorporated herein by reference, can beused. In accordance with a combination electric field-based and magneticfield-based system, the catheter can include both electrodes 28 asimpedance-based electrodes and one or more magnetic field sensing coils.Commonly available fluoroscopic, computed tomography (CT), and magneticresonance imaging (MRI)-based systems can also be used.

The irrigated catheter assembly can include other conventionalcomponents such as, for example and without limitation, conductorsassociated with the electrodes, and possibly additional electronics usedfor signal processing, visualization, localization, and/or conditioning.The irrigated catheter assembly can further include multiple lumens forreceiving additional components. Still referring to FIG. 1, theirrigated catheter assembly can further include a cable connector orinterface 32 and a handle 34. The cable connector or interface 32 canprovide mechanical, fluid, and electrical connection(s) for cables 36,38, 40 extending from the pump 26 and/or an ablation system 42 asdescribed in more detail below. The cable connector or interface 32 canbe conventional in the art and can be disposed at the proximal end ofthe irrigated catheter assembly. The handle 34 can provide a locationfor the clinician to hold the irrigated catheter assembly and canfurther provide means for steering or guiding the catheter shaft 18within the body 20 as known in the art. Catheter handles are generallyconventional in the art and it will be understood that the constructionof the handle can vary. In an embodiment, for the purpose of steeringthe catheter shaft 18 within the body 20, the handle 34 can besubstituted by a controllable robotic actuator.

Referring now to FIGS. 1-4, ablation electrode assembly 10 can beconnected to and/or coupled with the catheter shaft 18. Ablationelectrode assembly 10 can be disposed at or near the distal end of thecatheter shaft 18. Ablation electrode assembly 10 can be disposed at theextreme distal end (e.g., tip) of the catheter shaft 18. Referring nowto FIGS. 2-3, the ablation electrode assembly 10 can include anelectrode core member 44 and an electrode shell 46 in accordance with afirst embodiment of the disclosure. The lengths and/or diameters ofablation electrode assembly 10, electrode core member 44, electrodeshell 46, as well as portions thereof, can vary depending on the designof ablation electrode assembly 10. The electrode shell 46 can be aboutfour millimeters in length in an embodiment. Although four millimetersis mentioned in detail, the length of the electrode shell 46 can vary inaccordance with various embodiments.

Electrode core member 44 is configured for coupling the ablationelectrode assembly 10 to the catheter shaft 18 and for routing variouscomponents to the electrode shell 46. Electrode core member 44 has afirst end 48 and a second end 50. First end 48 can be a distal end, andsecond end 50 can be a proximal end in accordance with an embodiment ofthe disclosure. Electrode core member 44 can be generally cylindrical inshape. The first end 48 of the electrode core member 44 can be generallyflat in accordance with an embodiment of the disclosure. The first end48 of the electrode core member 44 can be partially spherical orgenerally hemispherical in shape in accordance with other embodiments ofthe disclosure. Although these particular shapes are mentioned indetail, the shape of the first end 48 of the electrode core member 44can vary in accordance with various embodiments of the disclosure. Thesecond end 50 of the electrode core member 44 can be configured forcoupling and/or connecting electrode core member 44 with the cathetershaft 18. The second end 50 of the electrode core member 44 can also beconfigured to receive the fluid delivery tube 22. The electrode coremember 44 can include multiple lumens for receiving any number ofcomponents (e.g., wires and the like) which can be routed through theelectrode core member 44. As best illustrated in FIG. 3, the electrodecore member 44 also has an outer surface 52 and an inner surface 54.Referring back to FIG. 2, the outer surface 52 of the electrode coremember 44 can include at least one channel 56 for receiving a thermalsensor 58.

Accordingly, the ablation electrode assembly 10 can include at least onethermal sensor 58 in accordance with an embodiment of the disclosure asbest shown in FIGS. 2-3. The ablation electrode assembly 10 can includethree thermal sensors 58 in accordance with an embodiment of thedisclosure. The thermal sensors 58 can be substantially equally spacedaround the periphery or circumference of the electrode core member 44.Although three sensors that are substantially equally spaced arementioned in detail, the ablation electrode assembly 10 can includefewer or more thermal sensors 58 in other embodiments and the locationof the thermal sensors 58 can vary in other embodiments. For example, inan embodiment, a single thermal sensor 58 may be centered within theablation electrode assembly 10. Thermal sensors 58 can be connectedand/or coupled to electrode core member 44 (and/or ablation electrodeassembly 10) in any manner that is conventional in the art to holdthermal sensors 58 in place relative to electrode core member 44 (and/orablation electrode assembly 10). Thermal sensors 58 are configured formeasurement and temperature control/regulation of ablation electrodeassembly 10. Thermal sensors 58 can be any mechanism known to one ofordinary skill in the art, including for example and without limitation,thermocouples and/or thermistors. Thermal sensors 58 can comprise othertypes of devices, such as for example and without limitation, devicesfor determining pressure, temperature and a flow parameter of a flowingfluid available from Radi Medical Systems AB, and as generally shownwith reference to at least U.S. Pat. No. RE39,863 entitled, the entiredisclosure of which is incorporated herein by reference.

At least a portion of the thermal sensors 58 can also be routed throughthe electrode shell 46. At least a portion of the thermal sensors 58 canbe surface mounted to an inner surface 86 of the electrode shell 46 inaccordance with an embodiment of the disclosure. At least a portion ofthe thermal sensors 58 can be surface mounted to the inner surface 86 ofthe electrode shell 46 in any manner known to those of ordinary skill inthe art. Referring now to FIG. 4, the electrode shell 46 can include areceptacle 59 for receiving at least a portion of the thermal sensor 58described hereinabove which can be routed through the electrode shell 46in accordance with an embodiment of the disclosure. For example andwithout limitation, the electrode shell 46 can include a tab extension(not shown) extending radially inwardly from the inner surface 86 of theelectrode shell 46 having at least one receptacle through which at leasta portion of the thermal sensor 58 can be routed. Although a tabextension is mentioned in detail, other structures can be utilized toprovide a receptacle through which the thermal sensors 58, or any numberof other components, can be routed.

Inner surface 54 of the electrode core member 44 defines an inner cavity60 as best illustrated in FIG. 3. In an embodiment of the disclosure,the electrode core member 44 includes an irrigation passageway 62 thatextends from the inner cavity 60 to the outer surface 52 of theelectrode core member 44. Electrode core member 44 includes a pluralityof irrigation passageways 62 in an embodiment. Each of the irrigationpassageways 62 extend from the inner cavity 60 of the electrode coremember 44 to the outer surface 52 of the electrode core member 44. Eachof the irrigation passageways 62 can be located closer to the first end48 of the electrode core member 44 than to the second end 50 of theelectrode core member 44 in accordance with an embodiment of thedisclosure. Each of the irrigation passageways 62 can generally extendradially outwardly. The ablation electrode assembly 10 can include alongitudinal axis 64. In an embodiment, each of the irrigationpassageways 62 can be oriented at about 90 degrees relative to thelongitudinal axis 64 of the ablation electrode assembly 10. Inaccordance with other embodiments, one or more of the irrigationpassageways 62 can be angled generally toward the first end 48 of theelectrode core member 44 at an acute angle (e.g., between about 20 toabout 70 degrees, and for some embodiments, between about 30 to about 65degrees) with respect to the longitudinal axis 64 of the ablationelectrode assembly 10. The orientation of the irrigation passageways 62vary depending on the design of the ablation electrode assembly 10. Theirrigation passageways 62 of the electrode core member 44 can bestraight or curved in various embodiments of the disclosure. Inaccordance with an embodiment of the disclosure, the irrigationpassageways 62 of the electrode core member 44 can be diametricallyopposed to each other around the perimeter or circumference of theelectrode core member 44. Each of the irrigation passageways 62 can begenerally tubular and can have a constant diameter along their length.In an embodiment, each of the irrigation passageways 62 can have adiameter ranging in size from about 0.008 inches (about 0.20 millimetersor about 1.04 F) to about 0.015 inches (about 0.38 millimeters or about1.95 F), and for some embodiments between about 0.010 inches (about 0.25millimeters or about 1.30 F) to about 0.012 inches (about 0.30millimeters or about 1.56 F). Alternate configurations having variousshapes and diameters, for example, along all or portions of the lengthof the irrigation passageways 62 can be used in various embodiments.Each of the irrigation passageways 62 can be configured to provideproximal delivery of irrigation fluid. Delivery of irrigation fluidgenerally reduces char and coagulum formation, thereby enabling greaterenergy delivery during RF ablation.

Electrode core member 44 can comprise a thermal insulator having areduced thermal conductivity. Electrode core member 44 can be thermallynonconductive in accordance with an embodiment of the disclosure.Electrode core member 44 can comprise an electrically nonconductivematerial in accordance with an embodiment of the disclosure. In general,the electrode core member 44 is lower in thermal conductivity, andpreferably substantially lower, than the electrode shell 46. Electrodecore member 44 can comprise a reduced thermally conductive polymer inaccordance with an embodiment of the disclosure. A reduced thermallyconductive polymer is one with physical attributes that decrease heattransfer by about 10% or more, provided that the remaining structuralcomponents are selected with the appropriate characteristics andsensitivities desired for the ablation electrode assembly 10. Onereduced thermally conductive material can include polyether ether ketone(PEEK). Additional examples of thermally nonconductive or reducedthermally conductive materials that can be useful in conjunction withthe instant disclosure include, but are not limited to, high densitypolyethylene (HDPE), polyimide thermoplastic resins, such as thoseresins sold under the trademark ULTEM® and as generally available fromGeneral Electric Plastics (now known as SABIC Innovative Plastics),polyaryletherketones, polyurethane, polypropylene, orientedpolypropylene, polyethylene, crystallized polyethylene terephthalate,polyethylene terephthalate, polyester, polyetherimide, acetyl, ceramics,and/or various combinations thereof. Electrode core member 44 can alsocomprise other plastic materials such as silicone or polyether blockamides such as those sold under the trademark PEBAX® and generallyavailable from Arkema France in other embodiments of the disclosure.

Electrode shell 46 is a relatively thin shell defining an inner volumeas best illustrated in FIGS. 2-3. Electrode shell 46 is configured toimprove temperature correlation between the electrode and tissueinterface because it is a relatively thin shell in place of a solid mass(i.e., requiring less time for the electrode shell 46 to register anincreased temperature due to the application of energy). Electrode shell46 can be a relatively thin shell (i.e., have a small thickness) and canbe external to and/or surround at least the first end 48 of theelectrode core member 44. Electrode shell 46 can comprise a single layerin accordance with an embodiment of the disclosure.

At least a portion of electrode shell 46 may be generally flexible in anembodiment. For example, at least a portion of electrode shell 46 may beconfigured to conform to the targeted tissue 14, and may therefore,deflect and/or undergo deformation when electrode shell 46 comes intophysical contact with the targeted tissue 14. In particular, theelectrode shell 46 can be sufficiently flexible so that at least adistal portion of electrode shell 46 may be configured for deformationand/or deflection in a number of directions relative to the longitudinalaxis 64 of ablation electrode assembly 10.

Referring now to FIG. 4, the electrode shell 46 is shown in a deflectedand/or deformed position 46 _(deflected), and is schematically showndeflected at an angle α relative to axis 64. Although this particulardeflection is illustrated, electrode shell 46 may be deflected and/ordeformed in various other ways, including in a direction along differentaxes other than the axis of the ablation electrode assembly 10.Deflection and/or deformation of the electrode shell 46 can allow theelectrode shell 46 to conform to cardiac anatomy in order to improveenergy efficiency during RF ablation.

Electrode shell 46 can be comprised of any electrically, and potentiallythermally, conductive material known to those of ordinary skill in theart for the delivery of ablative energy to targeted tissue areas.Examples of electrically conductive materials include gold, platinum,iridium, palladium, stainless steel, and/or any combination thereof. Inparticular, a combination of platinum and iridium can be used in variouscombinations. Electrode shell 46 can be fabricated or constructed inaccordance with any method or technique known to one of ordinary skillin the art. For example and without limitation, electrode shell 46 canbe fabricated or constructed using so-called deep drawn metal formingtechniques, metal-punching techniques, electroforming techniques (e.g.,electroforming over a sacrificial form that can include rods or otherinternal forms that melt or are subsequently dissolved), powdered metaltechniques (e.g., pressing powered metal into a slug, sintering at highheat, and then covering the pressed and sintered slug with a metalliccovering member), liquid metal injection molding (MIM) techniques, andthe like. The powered metal techniques can also include sacrificialmembers, and the pressed and sintered slug can itself conduct fluid andthermal energy inside, around, and against the metallic covering.

Referring to FIGS. 5A-5B, in accordance with an embodiment of thedisclosure wherein the electrode shell 46 comprises a metal, theelectrode shell 46 is comprised of a single member that is formed into ahelix, or spiral, and extends from distal end 78 to proximal end 80 orat least a portion thereof. For example and without limitation, at leasta portion of the electrode shell 46 can be similar to the tip elementdescribed and illustrated in U.S. Patent Application Publication No.2010/0174177, the entire disclosure of which is incorporated herein byreference. Referring again to FIGS. 5A-5B, at least a portion of theelectrode shell 46 includes a first set of projections 66 defining atleast in part a corresponding first set of recesses 68. At least aportion of the electrode shell 46 includes a second set of projections70 defining at least in part a corresponding second set of recesses 72.The first set of projections 66 and the second set of projections 70 arealternately spaced and extend away from the electrode shell 46 inopposite directions from one another along the length of the helix orspiral. In particular, each of the first set of projections 66 extendproximally (i.e., away from the distal end 78 of the electrode shell46), and each of the second set of projections 70 extend distally (i.e.,toward the distal end 78 of the electrode shell 46). The first set ofprojections 66 can be staggered and/or offset from the second set ofprojections 70 such that the first set of projections are positionedbetween the second set of projections 70. The first set of recesses 68and the second set of recesses 72 are complementary in shape to an outercontour of the first set of projections 66 and the second set ofprojections 70, respectively, but inversely shaped from same. In theembodiment of the disclosure illustrated in FIG. 5A, each of the firstset of projections 66, the first set of recesses 68, the second set ofprojections 70, and the second set of recesses 72 are trapezoidal inshape. Although a trapezoidal shape is mentioned in detail, theprojections 66, 70 and recesses 68, 72 can be any other number of othershapes in accordance with other embodiments of the disclosure. Forexample and without limitation, in the embodiment of the disclosureillustrated in FIG. 5B, each of the first set of projections 66, thefirst set of recesses 68, the second set of projections 70, and thesecond set of recesses 72 can be rounded (e.g., teardrop) in shape.

The electrode shell 46 can be fabricated such that the projections 66from a section of the electrode shell 46 extend into, and are capturedwithin, recesses 72 from an adjacent section of electrode shell 46 toform an interlocking arrangement. In addition, projections 70 from asection of the electrode shell 46 extend into, and are captured within,recesses 68 from an adjacent section of electrode shell 46 to form aninterlocking arrangement. Accordingly, at least one of the first set ofprojections 66 is configured to interlock with at least one of thesecond set of recesses 72, and at least one of the second set ofprojections 70 is configured to interlock with at least one of the firstset of recesses 68. Due to projections 66, 70 being complementary inshape to recesses 72, 68, respectively, and thus defining sockets orcompartments for projections 66, 70, projections 66, 70 are moveableonly a defined distance within recesses 72, 68. In particular, electrodeshell 46 is positionable to create a space or gap 74 between leadingedges of projections 66, 70 and inner edges or recesses 72, 68,respectively. Projections 66, 70 and recesses 68, 72 of the electrodeshell 46 extend along at least more than half the length of electrodeshell 46. For example and without limitation, projections 66, 70 andrecesses 68, 72 extend along at least two thirds of the length of theelectrode shell 46. Although these lengths are mentioned in detail,projections 66, 70 and recesses 68, 72 can extend for more or less ofthe entire length of the electrode shell 46 in accordance with variousembodiments of the disclosure. For example and without limitation, theprojections 66, 70 and recesses 68, 72 can be uniformly spaced along thelength of the electrode shell 46 and can also be uniformly spaced aroundthe perimeter (e.g., circumference) of the electrode shell 46. Althoughuniform spacing is mentioned in detail, projections 66, 70 and recesses68, 72 can be differently spaced along the length and/or perimeter ofthe electrode shell 46 in accordance with various embodiments of thedisclosure. For example and without limitation, the projections 66, 70and recesses 68, 72 can be uniformly sized along the length of theelectrode shell 46 and can be uniformly sized around the perimeter(e.g., circumference) of the electrode shell 46. Although uniform sizingis mentioned in detail, projections 66, 70 and recesses 68, 72 can bedifferently sized along the length and/or perimeter of the electrodeshell 46 in accordance with various embodiments of the disclosure.

As a consequence of gaps 74, and also the complementary shape ofprojections 66, 70 and recesses 68, 72, projections 66, 70 are provideda freedom of movement within recesses 68, 72 without being able to beremoved therefrom. Accordingly, sections of electrode shell 46 can movetoward and away from each other a defined distance to decrease andincrease, respectively, gaps 74. The ability of sections of electrodeshell 46 to move toward and away from each other a defined distance todecrease and increase, respectively, gaps 74 can constrain the flexureof the electrode shell 46 and limit the range of extensibility of theelectrode shell 46.

It is possible for sections of electrode shell 46 to move relative toone another in multiple ways. For example, the electrode shell 46 can becompressed so that all of gaps 74 are closed, or nearly closed, toreduce the longitudinal length of the electrode shell 46 by thecumulative dimensions of gaps 74 along a longitudinal axis 64.Additionally, sections of electrode shell 46 can exhibit cascaded and/orsequential movement along longitudinal axis 64 wherein some gaps 74 areclosed along longitudinal axis 64 while other gaps remain open, eitherpartially or fully. This allows gaps 74 between any adjacent sections ofthe electrode shell 46 to be opened or closed in an uneven ornon-uniform manner. As such, gaps 74 ₁ on a first portion of theperimeter (e.g., circumference) of the electrode shell 46 may be closedwhile gaps 74 ₂ on another second portion (e.g., opposing the firstportion) of the electrode shell may be opened. The result of such aconfiguration is that the electrode shell 46 curves in the direction ofthe closed gaps 74 ₁ and away from the direction of the opened gaps 74₂. It can be appreciated that movement in vertical and horizontal planescan simultaneously occur due to the interlocking construction ofelectrode shell 46 to flex and deflect at least the distal end 78 of theelectrode shell 46 to a practically unlimited number of positions. Atleast a portion of the electrode shell 46 can deflect in the mannerdescribed due to, for example and without limitation, impact forces onan outer surface 84 of the electrode shell 46 in use. The projections66, 70 and recesses 68, 72 can be configured to allow the electrodeshell 46 to have sufficient flexibility for deformation and/ordeflection of at least a portion of the electrode shell 46 for allowingthe electrode shell 46 to conform to cardiac anatomy in order to improveenergy efficiency of the delivery of ablation energy. This is becausethe flexible electrode shell 46 can engage a larger surface area uponcontact with targeted tissue 14, thereby improving contact stability andoptimizing energy transfer to the targeted tissue 14 while reducingcatheter induced mechanical stress.

The interlocking projections 66, 70 and recesses 68, 72 can befabricated and/or generated by laser-cutting techniques known to thoseof ordinary skill in the art. For example and without limitation,electrode shell 46 is laser cut from a material suitable for surgicaluse, such as an electrically conductive, non-corrosive material. Asdescribed hereinabove, examples of suitable materials include gold,platinum, iridium, palladium, stainless steel, and/or any combinationthereof. Projections 66, 70 and recesses 68, 72 can be laser cut out ofa cylindrical piece of material. As the number of helices increases inelectrode shell 46, the flexing capability of the electrode shell 46also increases. In addition, as the pitch of the helix (i.e., thedistance along the axis of the helix corresponding to one turn)decreases, the ability of the electrode shell 46 to move relative toitself increases. The flexibility can be further adjusted by providingdifferent numbers and shapes of projections 66, 70 and recesses 68, 72to produce an electrode shell 46 that flexes to varying degrees to meetdifferent objectives. For example and without limitation, RF energy canbe more specifically targeted to desired tissue areas for ablationprocedures when electrode shell 46 is flexed than when it is not flexedand can provide physicians with additional positioning capability.

In accordance with another embodiment of the disclosure where theelectrode shell 46 comprises a metal, the electrode shell 46 may notinclude interlocking projections 66, 70 and recesses 68, 72, but caninstead comprise wound and/or braided metallic wires. The spacing and/orthe configuration of wires, including the distance between adjacentturns of the wire can vary in accordance with various embodiments of thedisclosure.

In accordance with another embodiment of the disclosure, the electrodeshell 46 can comprise a polymer material. In particular, the electrodeshell 46 can comprise an electrically conductive polymer. The polymercan comprise a silicone material, for example. The polymer can haveelectrically conductive particles dispersed therein at a predefineddensity in accordance with an embodiment of the disclosure. The densityof the electrically conductive particles can be defined to achieve adesired electrical conductivity. The electrically conductive particlescan comprise metal particles in an embodiment. For example and withoutlimitation, the electrically conductive particles can comprise a metalsuch as gold, silver, platinum, iridium, titanium, tungsten, or acombination thereof. The polymer material of the electrode shell 46 canbe the same as the polymer material described and illustrated in U.S.Patent Application Publication No. 2009/0171188, the entire disclosureof which is incorporated herein by reference.

Referring back to FIGS. 2-3 in particular, electrode shell 46 has afirst end 78 and a second end 80. The first end 78 can be a distal end,and the second end 80 can be a proximal end in accordance with anembodiment of the disclosure. Electrode shell 46 can be generallycylindrical in shape. The first end 78 of the electrode shell 46 can bepartially spherical or generally hemispherical in shape in accordancewith an embodiment of the disclosure. The second end 80 of the electrodeshell 46 can be configured for mechanical connection to the electrodecore member 44. For example and without limitation, the second end 80 ofthe electrode shell 46 can be configured for mechanical connection tothe first end 48 of the electrode core member 44. Electrode shell 46 canbe coupled together or connected with electrode core member 44 along thesame longitudinal axis 64. Electrode core member 44 and electrode shell46 can be mechanically connected or coupled together by any knownmechanisms including, for example and without limitation, adhesivebonding, press-fit configurations, snap-fit configurations, ultrasonicstaking, mechanical deformation, or any other mechanism known to one ofordinary skill in the art. In an embodiment, the electrode shell 46 canbe configured for mechanical connection to the first end 48 of theelectrode core member 44. The first end 48 of the electrode core member44 can have an outer diameter that is substantially equal to the innerdiameter of the electrode shell 46 at the second end 80 of the electrodeshell 46. The electrode core member 44 can also include a radiallyoutwardly extending flange 82 near the first end 48 of the electrodecore member 44. The radially outwardly extending flange 82 has an outerdiameter that is substantially equal to the outer diameter of theproximal end 80 of the electrode shell 46.

The electrode shell 46 also has an outer surface 84 and inner surface 86as best illustrated in FIG. 3. In an embodiment, at least one retainingwire and/or safety wire (not shown) can be extended through a lumen inthe catheter shaft 18 and can be connected to the ablation electrodeassembly 10. The retaining wire and/or safety wire can comprise a hightensile strength liquid crystal polymer (LCP) fiber wire in accordancewith an embodiment of the disclosure. The retaining wire and/or safetywire can be configured to ensure that that the ablation electrodeassembly 10 is not separated from the catheter shaft 18 to which it isattached during movement of the irrigated catheter assembly within abody 20. One end of the retaining wire and/or safety wire can be affixedin the catheter 16, for example, using an anchor pin. An opposing end ofthe retaining wire and/or safety wire can be affixed to the electrodeshell 46. In particular, at least a portion of the retaining wire and/orsafety wire can be routed through the electrode shell 46. At least aportion of the retaining wire and/or safety wire can be surface mountedto the inner surface 86 of the electrode shell 46 in accordance with anembodiment of the disclosure. At least a portion of the retaining wireand/or safety wire can be surface mounted to the inner surface 86 of theelectrode shell 46 in any manner known to those of ordinary skill in theart. Referring now to FIG. 4, the electrode shell 46 can include areceptacle 87 for receiving at least a portion of the retaining wireand/or safety wire described hereinabove which can be routed through theelectrode shell 46 in accordance with an embodiment of the disclosure.For example and without limitation, the electrode shell 46 can include atab extension (not shown) extending radially inwardly from the innersurface 86 of the electrode shell 46 having at least one receptaclethrough which at least a portion of the retaining wire and/or safetywire can be routed and affixed to the electrode shell 46. Although a tabextension is mentioned in detail, other structures can be utilized toprovide a receptacle through which the thermal sensors 58, or any numberof other components, can be routed. The retaining wire and/or safetywire can be affixed to the electrode shell 46 by tying a knot in the endof the retaining wire and/or safety wire and press-fitting the knottedend into a receptacle 87. Adhesive can then be applied to bond the knotand the retaining wire and/or safety wire into the receptacle 87.

In accordance with an embodiment of the disclosure, a plug and/orbladder 88 can be configured to fill the inner volume defined by theelectrode shell 46. The plug and/or bladder 88 can also providestability for the electrode shell 46 and maintain some degree ofresistance to deflection (i.e., a recovery force) in some embodiments ofthe disclosure. The plug and/or bladder 88 is best illustrated in FIG.3. The plug and/or bladder 88 can comprise a polymer in accordance withan embodiment of the disclosure. For example and without limitation, thepolymer can comprise silicone. The plug and/or bladder 88 can berelatively soft in accordance with an embodiment of the disclosure. Forexample and without limitation, the durometer of the plug and/or bladder88 can be modified and/or adjusted to provide varying degrees offlexibility based on the desired characteristics of the end user of theablation electrode assembly 10. In other words, the plug and/or bladder88 can have a predefined durometer to achieve a desired flexibility. Theplug and/or bladder 88 can be configured to prevent ingress of bloodand/or fluids into the volume defined by the electrode shell 46. Theelectrode shell 46 and plug and/or bladder 88 can be immediately and/ordirectly adjacent to each other in an embodiment of the disclosure. Theelectrode shell 46 and plug and/or bladder 88 can define a spacetherebetween in accordance with other embodiments of the disclosure. Theconfiguration of the space can vary greatly and can be regular orirregular and can include support members (e.g., flutes, bosses, posts,and the like) to maintain separation between the electrode shell 46 andthe plug and/or bladder 88 in some embodiments of the disclosure. Thespace can be configured as an annular space in accordance with anembodiment of the disclosure.

Electrode shell 46 can be electrically connected to an ablation system42 to allow for the delivery of ablative energy, or the like. Electrodeshell 46 can be electrically connected to an ablation system 42 in anymanner conventional in the art. For example, a power wire 90 (bestillustrated in FIGS. 2-3) can be provided within electrode core member44 and electrode shell 46 of ablation electrode assembly 10. The powerwire 90 can extend through a lumen(s) provided within the ablationelectrode assembly 10. At least a portion of the power wire 90 can besurface mounted to the inner surface 86 of the electrode shell 46 inaccordance with an embodiment of the disclosure. At least a portion ofthe power wire 90 can be surface mounted to the inner surface 86 of theelectrode shell 46 in any manner known to those of ordinary skill in theart. Referring again to FIG. 4, the electrode shell 46 can include areceptacle 91 for receiving at least a portion of the power wire 90described hereinabove which can be routed through the electrode shell 46in accordance with an embodiment of the disclosure. For example andwithout limitation, the electrode shell 46 can include a tab extension(not shown) extending radially inwardly from the inner surface 86 of theelectrode shell 46 through which at least a portion of the power wire 90can be routed. Although a tab extension is mentioned in detail, otherstructures can be utilized to provide a receptacle through which thepower wire 90, or any number of other components, can be routed.

Referring back to FIG. 1, the ablation system 42 can be comprised of,for example, an ablation generator 92 and one or more ablation patchelectrodes 94. The ablation generator 92 generates, delivers, andcontrols ablation energy (e.g., RF) output by the irrigated catheterassembly and the electrode shell 46 of the ablation electrode assembly10 thereof, in particular. The generator 92 can be conventional in theart and can comprise a commercially available unit sold under the modelnumber IBI-1500T RF Cardiac Ablation Generator, available from St. JudeMedical, Inc. In an exemplary embodiment, the generator 92 can includean RF ablation signal source 96 configured to generate an ablationsignal that is output across a pair of source connectors: a positivepolarity connector SOURCE (+), which electrically connects to theelectrode shell 46 of the ablation electrode assembly 10 of theirrigated catheter assembly; and a negative polarity connector SOURCE(−), can be electrically connected to one or more of the patchelectrodes 94. It should be understood that the term connectors as usedherein does not imply a particular type of physical interface mechanism,but is rather broadly contemplated to represent one or more electricalnodes (including multiplexed and de-multiplexed nodes). The source isconfigured to generate a signal at a predetermined frequency inaccordance with one or more user specified control parameters (e.g.,power, time, etc.) and under the control of various feedback sensing andcontrol circuitry. The source can generate a signal, for example, with afrequency of about 450 kHz or greater for RF energy. The generator 92can also monitor various parameters associated with the ablationprocedure including, for example, impedance, the temperature at thedistal tip of the irrigated catheter assembly, applied ablation energy,power, force, proximity, and the position of the irrigated catheterassembly, and provide feedback to the clinician or another componentwithin the irrigated catheter assembly regarding these parameters.

Still referring to FIG. 1, the ablation system 42 can further include acontrol system 98. The control system 98 is configured to determine thetemperature of the targeted tissue 14 (i.e., the tissue to be ablated)and/or an appropriate ablation technique. The electrode shell 46 of theablation electrode assembly 10 can be connected to the control system 98with wires. The ablation generator 92 can form part of the controlsystem 98 in accordance with some embodiments or can be separate fromthe control system 98 in other embodiments. The thermal sensors 58 canbe connected to the control system 98. For example and withoutlimitation, wires can extend through lumens in the catheter. Devices fordetermining pressure, temperature, and a flow parameter of a flowingfluid available from Radi Medical Systems AB, and as generally shownwith reference to at least U.S. Pat. No. RE39,863, the entire disclosureof which is incorporated herein by reference can be used to monitorand/or control the quantity of flow of irrigation fluid within or fromthe catheter at one or more locations using a flow-from pressurealgorithm as described therein or as known to those of ordinary skill inthe art. These devices for determining pressure, temperature, and a flowparameter of a flowing fluid can also be connected to the control system98. The energy provided to the ablation electrode assembly 10 can beincreased by the control system 98 by increasing the power and/or lengthof energy delivery (e.g., amplitude and/or operating time) during theablation cycle. The energy provided to the ablation electrode assembly10 can be reduced by decreasing the power and/or length of time ofenergy delivery (e.g., frequency and/or operating time) during theablation cycle. The ablation technique that is selected by the controlsystem 98 can be selected to produce a certain, predeterminedtemperature in the targeted tissue 14 that will form a desired lesion inthe targeted tissue 14. While the desired lesion can be transmural insome embodiments, the characteristics of the desired lesion can varysignificantly. The certain, predetermined temperature in the targetedtissue 14 that will form a desired lesion in the targeted tissue 14 canbe affected by the thermal response of the targeted tissue. The thermalresponse of the targeted tissue 14 can be affected by a number ofvariables including tissue thickness, amount of fat and muscle, bloodflow through the region, and blood flow at the interface of the ablationelectrode assembly 10 and the targeted tissue 14.

Referring back to FIGS. 2-4, in accordance with an embodiment of thedisclosure, the ablation electrode assembly 10 further includes anirrigant distribution element 100. Irrigant distribution element 100 canbe configured as a generally annular ring in accordance with anembodiment of the disclosure. The irrigant distribution element 100 hasa first end 102 and a second end 104. The first end 102 can be aproximal end, and the second end 104 can be a distal end in accordancewith an embodiment of the disclosure. At least a portion of the firstend 102 of the irrigant distribution element 100 can engage a cathetershaft 18 in which the electrode core member 44 can be located. At leasta portion of the second end 104 of the irrigant distribution element 100can surround and/or encircle at least a portion of the electrode coremember 44 and further, can define a circumferential irrigation port 106between the irrigant distribution element 100 and the electrode coremember 44 in accordance with an embodiment of the disclosure.

Irrigant distribution element 100 is configured to guide irrigationfluid toward electrode shell 46 about and along outer surface 84 of theelectrode shell 46, and in particular, direct the fluid (e.g., irrigant)flow in a direction substantially parallel with the outer surface 84 ofthe electrode shell 46. Irrigant distribution element 100 can include afluid shaping member 108 that helps ensure that the fluid flow tendstoward the surface 84 of the electrode shell 46 of the ablationelectrode assembly 10. For example and without limitation, the fluidshaping member 108 of the irrigant distribution element 100 can includea channel, rifling, boss, hump, chamfer, and/or combination thereof on asurface of the irrigant distribution element 100 defining thecircumferential irrigation port 106. As illustrated in FIG. 6, the fluidshaping member 108 is configured to disturb fluid flow (e.g., causefluid flowing closer to the outer surface 52 of the electrode coremember 44 to slow down relative to fluid flowing farther from the outersurface 52 of the electrode core member 44), thereby helping to ensurethat the fluid flow tends toward the surface 84 of the electrode shell46. In this way, the flow of irrigant can be turbulent in order toprovide an enveloping flow pattern adjacent to the outer surface 84 ofthe electrode shell 46 of the ablation electrode assembly 10 for mixingwith, displacing, and/or diluting blood that can be in contact with theablation electrode assembly 10 in order to help prevent stasis and theformation of coagulum. Although flexing of the electrode shell 46 canaffect the flow of irrigant, it is expected that the flexing of theelectrode shell 46 will not have a significant clinical impact since anyflexing and/or deflection of the electrode shell 46 is limited andrelatively small in accordance with an embodiment of the disclosure.

The configuration of irrigant distribution element 100 can improve fluidflow of the irrigation fluid such that the total flow rate (or volumedelivered per unit of time) of irrigation fluid can be exceedingly lowas compared to traditional irrigation flow rates (and volumes). In otherwords, overall total fluid volumes of irrigation fluid can be much lowerthan the prior art or than those fluid volumes typically utilized inclinical practice, which can be especially valuable for patients alreadysuffering from fluid overload (e.g., patient having heart failure andthe like). Overall total fluid volume can range from low single digitsto about ten or so milliliters per minute while effectively reducing oreliminating char and coagulum and improving temperature correlation forprecise control of power to maintain a temperature during ablationprocedures.

Valve members, for example and without limitation, such as those shownand described in co-owned U.S. Patent Application Publication No.2008/0161795, the entire disclosure of which is incorporated herein byreference, or other similar flow control features can be used inconnection with catheters incorporating ablation electrode assembly 10in order to change the flow rate of irrigation fluid. In otherembodiments, the flow control features can be part of an ancillarycontrol system separate from and to be used in conjunction withcatheters. The valves can operate automatically without user inputand/or can operate based on feedback recorded during RF ablation by theECU of the visualization, navigation, and/or mapping system 30. Thefeedback can relate to time, temperature, and/or impedance, for exampleand without limitation. Circuitry for implementing the feedbackautomatically in a control algorithm can be readily provided by thosehaving ordinary skill in the art after becoming familiar with theteachings herein.

Referring now to FIGS. 7-8, ablation electrode assembly 10′ can includean electrode core member 44′ and an electrode shell 46′ in accordancewith a second embodiment. The ablation electrode assembly 10′ inaccordance with a second embodiment of the disclosure can besubstantially identical to the ablation electrode assembly 10 asdescribed hereinabove including the electrode shell 46′ being generallyflexible in an embodiment (e.g., configured to conform to the targetedtissue 14 by deflection and/or deformation when the electrode shell 46′comes into physical contact with the targeted tissue 14), except thatthe electrode core member 44′ and/or the electrode shell 46′ can bemodified to provide distal delivery of irrigation fluid in which atleast a portion of the irrigation fluid is transferred to a distalexhaust port. The ablation electrode assembly 10′ that is configured toprovide both proximal and distal delivery of irrigation fluid can beespecially beneficial to reduce thrombus formation and/or charring atthe distal end (e.g., tip) of the ablation electrode assembly 10′. Byproviding both proximal and distal delivery of irrigation fluid, it canfurther displace blood and prevent stasis in the areas adjacent theelectrode shell 46′ of the ablation electrode assembly 10′.

Still referring to FIGS. 7-8, ablation electrode assembly 10′ isconfigured for distal delivery of irrigation fluid with an axiallyextending passageway 110 extending from the inner cavity 60′ of theelectrode core member 44′ toward the first end 78′ of the electrodeshell 46′. The axially extending passageway 110 can be defined by agenerally cylindrical member 112. The generally cylindrical member 112can be integral with the inner core member 44′ in accordance withvarious embodiments of the disclosure. The generally cylindrical member112 can also be separate from the inner core member 44′ in accordancewith various other embodiments of the disclosure. For example andwithout limitation, the generally cylindrical member 112 may comprise aclose wound coil spring with a liner or jacket of low durometer polymer.For another example, the generally cylindrical member 112 may comprise apolymer tube. The cylindrical member 112 can be sufficiently flexible sothat at least a portion of the cylindrical member 112 may be configuredfor deformation and/or deflection in a number of directions relative tothe longitudinal axis 64 of ablation electrode assembly 10. Although themember 112 is defined as generally cylindrical, the member 112 cancomprise any number of various shapes in accordance with embodiments ofthe disclosure. In accordance with another embodiment of the disclosure,the axially extending passageway 110 can be defined by a through-holedisposed in the plug and/or bladder 88 configured to fill the innervolume defined by the electrode shell 46. As described hereinabove, theplug and/or bladder 88 can comprise silicone in accordance with anembodiment. The total range of deflection of cylindrical member 112and/or the plug and/or bladder 88 can be relatively small such thatstress on the conduit is not expected to adversely affect the functionof the ablation electrode assembly 10′.

In accordance with one embodiment of the disclosure, the axiallyextending passageway 110 can extend to the distal end 78′ of theelectrode shell 46′. In accordance with another embodiment of thedisclosure as generally illustrated in FIGS. 7-8, the axially extendingpassageway 110 can transition into one or more ports 114 near the distalend 116 of the member 112. Port(s) 114 can be configured to enableirrigation fluid flowing through the axially extending passageway 110 toflow to a first end 78′ of the electrode shell 46′, thereinsubstantially irrigating the first end 78′ (e.g., tip) of electrodeshell 46′ of the ablation electrode assembly 10′. For example andwithout limitation, the member 112 can include three ports 114. Each ofthe port(s) 114 can be oriented at a generally acute angle (e.g., about45 degrees) relative to the longitudinal axis 64 of the ablationelectrode assembly 10′. The orientation of the port(s) 114 variesdepending on the design of the ablation electrode assembly 10′. Theport(s) 114 can be substantially equally spaced around the circumferenceof the member 112 in an embodiment of the disclosure. The port(s) 114are configured to extend from the distal end of the axially extendingpassageway 110 to the distal end 78′ of the electrode shell 46′.

In an embodiment of the disclosure, a coating (not shown) can bedisposed on at least a portion of the member 112 that defines theaxially extending passageway 110. For example and without limitation, acoating can be especially useful if the member 112 is not integral withthe inner core member 44′ and instead comprises a material that may beelectrically conductive. The coating can be comprised of an electricallynon-conductive material. For example and without limitation, the coatingcan be comprised of diamond, diamond-like carbon (DLC), orpolytetrafluoroethylene (PTFE), which is commonly sold by the E. I. duPont de Nemours and Company under the trademark TEFLON®. In anembodiment of the disclosure, the coating can be provided around theentire circumference and along the entire length of the axiallyextending passageway 110. However, the coating can be provided onlyaround a portion of the circumference and/or only along a portion of thelength of the axially extending passageway 110 in accordance withvarious embodiments of the disclosure. The amount of the coatingprovided around the circumference and/or length of the axially extendingpassageway 110 or portion thereof can vary depending on the relativerequirements of ablation electrode assembly 10′.

Although ablation electrode assemblies 10, 10′ are described andillustrated with a single electrode core member 44, 44′ and a singleelectrode shell 46, 46′, an ablation catheter 16 can include two or moreelectrode core members 44, 44′ and/or two or more electrode shells 46,46′ in accordance with various embodiments of the disclosure.Furthermore, although ablation electrode assemblies 10, 10′ aredescribed and illustrated such that the electrode shell 46, 46′ islocated distally of the electrode core member 44, 44′, at least oneelectrode shell 46, 46′ can be located proximally of an electrode coremember 44, 44′ in accordance with various embodiments of the disclosure.

For example and without limitation, an ablation electrode assembly 10″can include two or more electrode core members 44 ₁, 44 ₂ and a singleelectrode shell 46″ as generally illustrated in FIG. 9. The firstelectrode core member 44 ₁ can be disposed proximally relative to theelectrode shell 46. The first electrode core member 44 ₁ can besubstantially identical to the electrode core member 44, 44′ describedhereinabove. The second electrode core member 44 ₂ can be disposeddistally relative to the electrode shell 46. The second electrode coremember 44 ₂ can be substantially identical to the electrode core member44, 44′ described hereinabove; however, the second electrode core member44 ₂ can be oriented such that the first and second electrode coremembers 44 ₁, 44 ₂ face in opposing directions. Accordingly, the firstend 48 ₂ of the second electrode core member 44 ₂ can be a proximal end,and the second end (not shown) of the second electrode core member 44 ₂can be a distal end. Electrode shell 46″ can be substantially identicalto the electrode shell 46 described herein above. Electrode shell 46″can be generally cylindrical in shape, and both the first and secondends 78″, 80″ of the electrode shell 46″ can be open. In particular, thefirst end 78″ of the electrode shell 46″ can be configured forconnection to the second electrode core member 44 ₂ that is locateddistally of the electrode shell 46″, and the second end 78″ of theelectrode shell 46″ can be configured for connection to the firstelectrode core member 44 ₁ that is located proximally of the electrodeshell 46″.

The ablation electrode assembly 10″ generally illustrated in FIG. 9 canalso include two or more irrigant distribution elements 100 ₁, 100 ₂.Irrigant distribution elements 100 ₁, 100 ₂ can be substantiallyidentical to the irrigant distribution element 100 describedhereinabove. At least a portion of the first end 102 ₁ of the firstirrigant distribution element 100 ₁ can engage a catheter shaft 18 inwhich the first electrode core member 44 ₁ can be located. At least aportion of the second end 104 ₁ of the first irrigant distributionelement 100 ₁ can surround and/or encircle the first electrode coremember 44 ₁ and further, can define a circumferential irrigation port106 ₁ between the first irrigant distribution element 100 ₁ and theelectrode core member 44 ₁. The circumferential irrigation port 106 ₁ isconfigured to guide irrigation fluid toward electrode shell 46″, andtherefore, directs the irrigation fluid distally. At least a portion ofthe first end 102 ₂ of the second irrigant distribution element 100 ₂can engage a tip electrode 118. The tip electrode 118 may or may not beflexible in accordance with various embodiments of the disclosure. Atleast a portion of the second end 104 ₂ of the second irrigantdistribution element 100 ₂ can surround and/or encircle the secondelectrode core member 44 ₂, and further, can define a circumferentialirrigation port 106 ₂ between the second irrigant distribution element100 ₂ and the second electrode core member 44 ₂. The circumferentialirrigation port 106 ₂ is configured to guide irrigation fluid towardelectrode shell 46″, and therefore, directs the irrigation fluidproximally. An irrigant supply line 120 can be disposed between thefirst electrode core member 44 ₁ and the second electrode core member 44₂. The irrigant supply line 120 can be the same as or can be in fluidcommunication with the fluid delivery tube 22 disposed within thecatheter shaft 18.

Referring now to FIG. 10, ablation electrode assembly 10′″ can includetwo or more electrode core members 44 ₁, 44 ₂ and two or more electrodeshells 46″₁, 46 ₂. Although two electrode core members 44 ₁, 44 ₂ andtwo electrode shells 46″₁, 46 ₂ are generally illustrated, the ablationelectrode assembly 10′″ can include any number of electrode core members44 and electrode shells 46 in accordance with various embodiments of thedisclosure. The first electrode core member 44 ₁ can be disposedproximally relative to the first electrode shell 46″₁. The firstelectrode core member 44 ₁ can be substantially identical to theelectrode core member 44, 44′ described hereinabove. In addition, thefirst electrode shell 46″₁ can be substantially identical to theelectrode shell 46 described hereinabove. The first electrode shell 46″₁can be generally cylindrical in shape, and both the first and secondends 78″, 80″ of the first electrode shell 46″₁ can be open. Inparticular, the first end 78″ of the first electrode shell 46″₁ can beconfigured for connection to the second electrode core member 44 ₂ thatis located distally of the first electrode shell 46″₁, and the secondend 80″ of the electrode shell 46″₁ can be configured for connection tothe first electrode core member 44 ₁ that is located proximally of thefirst electrode shell 46″.

The second electrode core member 44 ₂ can be disposed proximallyrelative to the second electrode shell 46 ₂. The second electrode coremember 44 ₂ can be substantially identical to the electrode core member44, 44′ described hereinabove. The second electrode shell 46 ₂ can alsobe generally cylindrical in shape. First end 78 of the second electrodeshell 46 ₂ can be closed and can be hemispherical and/or spherical inshape. The first end 78 of the second electrode shell 46 ₂ can behemispherical and/or spherical in shape when the second electrode shell46 ₂ is disposed at the distal tip of the ablation electrode assembly10′″. However, the second electrode shell 46 ₂ does not have to bedisposed at the distal tip of the ablation electrode assembly.Accordingly, in other embodiments of the disclosure, the secondelectrode shell 46 ₂ can be disposed at any location along the ablationcatheter 16. Depending upon the location of the second electrode shell46 ₂, the first end 78 of the second electrode shell 46 ₂ can be open orclosed. The second end 80 of the second electrode shell 46 ₂ can be openand can be configured for connection to the second electrode core member44 ₂.

In some embodiments, the ablation electrode assembly 10′″ generallyillustrated in FIG. 10 can include two or more irrigant distributionelements 100 ₁, 100 ₂. Irrigant distribution elements 100 ₁, 100 ₂ canbe substantially identical to the irrigant distribution element 100described hereinabove. At least a portion of the second end 104 ₁, 104 ₂of each irrigant distribution element 100 ₁, 100 ₂ can surround and/orencircle each corresponding electrode core member 44 ₁, 44 ₂, andfurther can define a circumferential irrigation port 106 ₁, 106 ₂between the irrigant distribution element 100 ₁, 100 ₂ and the electrodecore member 44 ₁, 44 ₂. Each circumferential irrigation port 106 ₁, 106₂ is configured to guide irrigation fluid toward electrode shell 46″₁,46 ₂, and therefore, each irrigant distribution elements 100 ₁, 100 ₂directs the irrigation fluid distally. An irrigant supply line 120 canbe disposed between the first electrode core member 44 ₁ and the secondelectrode core member 44 ₂. The irrigant supply line 120 can be in fluidcommunication with the fluid delivery tube 22 disposed within thecatheter shaft 18. In accordance with various embodiments (and asgenerally illustrated in FIGS. 9-10), ablation electrode assemblies caninclude a series of two or more active ablation electrodes each with itsown dependent (e.g., common source) or independent (e.g., discretesource) irrigant distribution configuration.

Referring now to FIGS. 11-12, another embodiment of an ablationelectrode assembly 210 in shown. Assembly 210 is provided for ablationof tissue 14 in body 20. Assembly 210 is disposed about a longitudinalaxis 212 and has a proximal end 214 and a distal end 216. Assembly 210may include an electrode core member 218, an electrode shell 220 and anirrigant distribution element 222. Shell 220 and distribution element222 may be substantially similar to shell 46′ and distribution element100 described hereinabove.

Core member 218 is provided to couple assembly 210 to catheter shaft 18,for structural support of shell 220 and to route irrigation fluid andconductors. Member 218 is similar to member 44′ in assembly 10′described hereinabove except as stated below. Member 218 may be disposedabout and centered on axis 212. Member 218 has a proximal end 224 and adistal end 226. Proximal end 224 defines the proximal end 214 ofassembly 210 and is configured for coupling member 218 to catheter shaft18. Distal end 226 is disposed within a central bore of electrode shell218. Referring to FIG. 11, member 218 further defines a fluid manifold228 that extends from proximal end 224 to distal end 226. Manifold 228is configured for fluid communication with a fluid lumen in cathetershaft 18.

Manifold 228 may define a cavity 230 and irrigation pathways 232, 234that are substantially similar to cavity 60 and passageways 62 (or 62′),110 discussed hereinabove in connection with assembly 10′ in FIGS. 7-8.Passageway 234 may be centered about a longitudinal axis, such as axis212 extending in the longitudinal direction of assembly 210. Althoughpassageway 234 is shown as having a central axis that is co-axial withthe central axis 212 of assembly 210, it should be understood that thatpassageway 234 could alternatively be centered about an axis extendingparallel to the axis 212. Passageway 234 has a distal end 236 thatterminates prior to the distal end 226 of member 218 and the distal end216 of assembly 210. Manifold 228 may further define a pool 238 at thedistal end 226 of member 218 and the distal end 216 of assembly 210.Pool 238 may be substantially concave in shape such that the depth ofpool 238 is greatest at the center of pool 238.

In accordance with one embodiment, manifold 228 defines means, such asangled passageways 240, for creating turbulence in fluid exiting axialpassageway 234. Passageways 240 extend from distal end 236 of axialpassageway 234 towards distal end 216 of assembly 210 and terminate inpool 238. Each passageway 240 is in fluid communication with axialpassageway 234. Each passageway 240 defines a proximal inlet port 242disposed at the proximal end of passageway 240 and at the distal end 236of axial passageway 234. Each passageway 240 further defines a distaloutlet port 244 at a distal end of passageway 240. Each passageway 240is disposed about, and centered about, a longitudinal axis 246. Eachpassageway 240 is oriented such that the axes 246 of the passageways 240intersect axis 212 extending through passageway 234 and intersect oneanother. Further, the distal outlet port 244 of each passageway 240 isnearer to axis 212 than proximal inlet port 242 is to axis 212 and thedistance between distal outlet ports 244 on any two passageways 240 isless than a distance between corresponding inlet ports 242 of eachpassageway 240. Because of the orientation of passageways 238, irrigantthat exits axial passageway 234 flows along multiple paths and theirrigant flowing along any one path interferences with the irrigant flowalong other paths thereby expanding the coverage of the irrigant flow(as compared to a single undisturbed stream) and encouraging enhancedmixing with the blood near the ablation site and, therefore, improvedcooling of assembly 210 and the ablation site. FIGS. 13A and 13Billustrate irrigant flow from a distal end of an electrode assemblyhaving a single port at the distal end and electrode assembly 210,respectively (the irrigation port between distribution element 222 andcore member 218 is blocked for purposes of this illustration). As shownin FIGS. 13A-B, assembly 210 causes greater disturbance, and thereforeenhanced mixing with the blood, nearer to distal end 216 of assembly210. Although the illustrated embodiment shows two diametricallyopposite passageways 240, it should be understood that the number ofpassageways 240, and the spacing between them, may vary.

Referring now to FIGS. 14A-B, another embodiment of an ablationelectrode assembly 248 is shown. Assembly 248 is similar to assembly210, but employs different means for creating turbulence in fluidexiting axial passageway 234. Rather than angular passageways 240,assembly 248 employs one or both of a reduced diameter axial passageway250 and a wound coil spring 252 (FIG. 14A) or auger shaped fluiddirector 253 (FIG. 14B) within axial passageway 234. Passageway 250 isdisposed at distal end 236 of passageway 234 and may be centered aboutaxis 212. Passageway 250 extends from end 236 of passageway 234 to thedistal end of assembly 248. Passageway 250 has a smaller diameter thanpassageway 250 causing the direction of fluid flow to change andincreasing turbulence in the fluid flow. Spring 252 or director 253 isdisposed within passageway 234 and disturbs the irrigant flow as itexits the distal end 236 of passageway 234 in order to cause theirrigant stream to slow and expand when it encounters the blood pool.

Referring now to FIGS. 15A-B, another embodiment of an ablationelectrode assembly 254 is shown. Assembly 254 is similar to assemblies210 and 248, but again employs different means for creating turbulencein fluid exiting axial passageway 234. Rather than angular passageways240 or a wound coil spring 252 or fluid director 253, assembly 254employs a fluid deflector 256 (FIG. 15A) or 258 (FIG. 15B). Deflectors256, 258 may comprise wire having an elongate neck 260 anchored withinthe electrode assembly and an enlarged distal end or head in the form ofa ball 263 (FIG. 15A) or disc 264 (FIG. 15B). Irrigant passing betweenthe neck of the deflector 256 or 258 and the inner surface of thepassageway 234 is deflected by the ball 262 or disc 264 to createturbulence in the irrigant flow.

Although various embodiments of this disclosure have been describedabove with a certain degree of particularity, those skilled in the artcould make numerous alterations to the disclosed embodiments withoutdeparting from the spirit or scope of this disclosure. All directionalreferences (e.g., upper, lower, upward, downward, left, right, leftward,rightward, top, bottom, above, below, vertical, horizontal, clockwise,and counterclockwise) are only used for identification purposes to aidthe reader's understanding of the present disclosure, and do not createlimitations, particularly as to the position, orientation, or use of thedisclosure. Joinder references (e.g., attached, coupled, connected, andthe like) are to be construed broadly and can include intermediatemembers between a connection of elements and relative movement betweenelements. As such, joinder references do not necessarily infer that twoelements are directly connected and in fixed relation to each other. Itis intended that all matter contained in the above description or shownin the accompanying drawings shall be interpreted as illustrative onlyand not limiting. Changes in detail or structure can be made withoutdeparting from the spirit of the disclosure as defined in the appendedclaims.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. An ablation electrode assembly, comprising: aproximal portion configured to be coupled to a catheter shaft; a distalportion configured to deliver ablation energy to tissue; a fluidmanifold extending from said proximal portion to a distal end of thedistal portion and configured to fluidly communicate with a fluid lumenin the catheter shaft, said fluid manifold defining an axial passagewaycentered about a longitudinal axis extending in the longitudinaldirection of said assembly, said axial passageway having a longitudinalaxis and a distal end terminating at the distal end of the fluidmanifold; and, a fluid deflector disposed within the distal end of theaxial passageway, wherein the fluid deflector is configured to createturbulence in a fluid as it exits the fluid manifold, and wherein thefluid deflector is further configured to direct the fluid parallel tothe longitudinal axis of the axial passageway.
 2. The ablation electrodeassembly of claim 1 further comprising: an electrode core membercomprising a thermal insulator having a reduced thermal conductivity,said electrode core member defining said fluid manifold; and, anelectrode shell comprising an electrically conductive material, saidshell configured to be connected to said electrode core member.
 3. Theablation electrode assembly of claim 2 wherein said electrode shell issufficiently flexible for deflection of a distal end of said electrodeshell relative to a longitudinal axis of the ablation electrodeassembly.
 4. The ablation electrode assembly of claim 2 furthercomprising an irrigant distribution element surrounding at least aportion of the electrode core member, the irrigant distribution elementhaving: a first end; and, a second end, wherein the second end of theirrigant distribution element defines a circumferential irrigation portbetween the irrigant distribution element and the electrode core member.5. The ablation electrode assembly of claim 1 wherein at least a portionof the circumference and at least a portion of the length of the axialpassageway includes a coating of an electrically non-conductivematerial.
 6. An ablation electrode assembly, comprising: a proximalportion configured to be coupled to a catheter shaft; a distal portionconfigured to deliver therapeutic energy to tissue; a fluid manifoldcomprising a longitudinal axis and extending between the proximalportion and a distal end of the distal portion; and a fluid deflectordisposed within a distal end of the fluid manifold, wherein the fluiddeflector is configured to create turbulence in a fluid as it exits thefluid manifold, and wherein the fluid deflector is further configured todirect the fluid parallel to the longitudinal axis of the fluidmanifold.
 7. The ablation electrode assembly of claim 6, furthercomprising an electrode core member and an electrode shell, wherein theelectrode core member comprises a thermal insulator having a reducedthermal conductivity, and the electrode shell comprises an electricallyconductive material.
 8. The ablation electrode assembly of claim 6,further comprising an electrode shell, wherein the electrode shell issufficiently flexible for deflection of a distal end of the electrodeshell relative to a longitudinal axis of the ablation electrodeassembly.
 9. The ablation electrode assembly of claim 6, wherein thefluid manifold is configured to create turbulence in the proximalportion.
 10. The ablation electrode assembly of claim 9, wherein thefluid manifold is further configured to create turbulence in the distalportion.